Summary

for females ages 18-45 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion:
Candice Price (ucdavis)

Description

Summary

The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.

Official Title

Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.

Details

This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.

Keywords

Healthy Sugar-sweetened beverage

Eligibility

You can join if…

Open to females ages 18-45

  • BMI 25 - 35 kg/m2

You CAN'T join if...

  • Does not identify as African-American or non-hispanic White
  • Glucose intolerance (fasting glucose >100 mg/dl)
  • Evidence of liver disorder (AST or ALT >200% upper limit of normal range)
  • Evidence of kidney disorder (>2.0mg/dl creatinine)
  • Evidence of thyroid disorder (out of normal range)
  • Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
  • Triglycerides > 150mg/dl
  • LDL-C > 130mg/dl
  • Hemoglobin < 8.5 g/dL
  • Pregnant or lactating women
  • Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents PROTOCOL TITLE: The Effects of Sucrose Beverage on

African-American and Caucasian Women (SAAC) Study Page 4 of 18 Revised: November 27,2013

  • Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results
  • Use of chronic corticosteroids (everyday use for a month or longer)
  • Use of tobacco
  • Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking)
  • Surgery for weight loss
  • Diet exclusions: Food allergies, special dietary restrictions, food allergies, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu
  • Veins that are assessed by the CCRC R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter
  • Any other condition that, in the opinion of the investigators, would put the subject at risk
  • We will exclude individuals from each of the following special populations:
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers < 18 years)
  • Pregnant women
  • Prisoners

Locations

  • University of California, Davis accepting new patients
    Davis California 95616 United States
  • University of California, Davis CTSC Clinical Research Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT03611972
Study Type
Interventional
Last Updated